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NCT Number: NCT04634448

The Prevalence of Appendiceal Tumours in Periappendicular Abscess

Complicated and uncomplicated appendicitis follow different epidemiological trends also suggesting different pathophysiology behind these two different forms of appendicitis. In 3-10% of patients complicated acute appendicitis is enclosed by formation of a circumscribed periappendicular abscess. The clinically established practice of antibiotic therapy and drainage, if necessary, has been shown safe and effective, allowing the acute inflammatory process to subside in more than 90% of cases without surgery. The need of subsequent interval appendectomy has been questioned with appendicitis recurrence risk varying between 5-26%.

During trial enrollment in our randomized Peri-APPAC trial based on the interim analysis results with 17% appendiceal tumor rate in the study population, the trial was prematurely terminated based on ethical concerns. All the follow-up group patients were re-evaluated and surgery was offered and recommended to all follow-up group patients. After this assessment and additional appendectomies, two more tumors were diagnosed resulting in neoplasm rate of 20% in the whole study group all diagnosed in patients over 40 years and the neoplasm rate in patients over 40 years was 29%.

Based on high appendiceal tumor rate in patients over 40 years, the appendiceal neoplasm rate needs to be further evaluated in prospective patient cohorts undergoing interval appendectomy as interval appendectomy is generally well tolerated and obliterates the risk of missing a possible tumor. In a recent systematic review of retrospective cohort studies with 13.244 acute appendicitis patients the overall appendiceal tumor rate was 1% after appendectomy, but in patients presenting with appendiceal inflammatory mass the neoplasm rate varied from 10% to 29%.

This nationwide prospective multicenter cohort study is designed to assess the prevalence of appendiceal tumors associated with a periappendicular abscess. All consecutive patients presenting with a periappendicular abscess are recommended to undergo interval appendectomy after initial conservative treatment with antibiotic therapy and drainage, if necessary. All patients older than 35 years will undergo laparoscopic interval appendectomy at 2 to 3 months and this is also recommended for the patients between 18 and 35 years of age. Asymptomatic patients under 35 years not willing to undergo interval appendectomy, will undergo a follow-up MRI at 1 year after the initial non-operative treatment.

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Key information

About this study

Complicated and uncomplicated appendicitis follow different epidemiological trends also suggesting different pathophysiology behind these two different forms of appendicitis. In 3-10% of patients complicated acute appendicitis is enclosed by formation of a circumscribed periappendicular abscess. The clinically established practice of antibiotic therapy and drainage, if necessary, has been shown safe and effective, allowing the acute inflammatory process to subside in more than 90% of cases without surgery. The need of subsequent interval appendectomy has been questioned with appendicitis recurrence risk varying between 5-26%.

During trial enrollment in our randomized Peri-APPAC trial, the high incidence of appendiceal tumors in the study population alarmed the researchers. Based on the interim analysis results with 17% appendiceal tumor rate in the study population, the trial was prematurely terminated based on ethical concerns. All the follow-up group patients were re-evaluated and surgery was offered and recommended to all follow-up group patients. After this assessment and additional appendectomies, two more tumors were diagnosed resulting in neoplasm rate of 20% in the whole study group all diagnosed in patients over 40 years and the neoplasm rate in patients over 40 years was 29%.

Based on high appendiceal tumor rate in patients over 40 years, the appendiceal neoplasm rate needs to be further evaluated in prospective patient cohorts undergoing interval appendectomy as interval appendectomy is generally well tolerated and obliterates the risk of missing a possible tumor. In a recent systematic review of retrospective cohort studies with 13.244 acute appendicitis patients the overall appendiceal tumor rate was 1% after appendectomy, but in patients presenting with appendiceal inflammatory mass the neoplasm rate varied from 10% to 29%.

This nationwide prospective multicenter cohort study is designed to assess the prevalence of appendiceal tumors associated with a periappendicular abscess. All of the study hospitals will have a common clinical protocol of recommending interval appendectomy to all patients presenting with a periappendicular abscess after initial conservative treatment with antibiotic therapy and drainage, if necessary. Considering the high rate of appendiceal neoplasms, all patients older than 35 years will undergo laparoscopic interval appendectomy at 2 to 3 months after the successful initial non-operative treatment and this is also recommended for the patients between 18 and 35 years of age. Asymptomatic patients under 35 years not willing to undergo interval appendectomy, will undergo a follow-up MRI at 1 year after the initial non-operative treatment.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • periappendiceal abscess proven by CT, Mri or US

Exclusion criteria

  • patient declines to participate, complicated appendicitis without periappendiceal abscess

Treatment and study plan

interval appendectomy

Procedure

interval appendectomy at 2 to 3 months after the initial non-operative treatment

Follow-up MRI at 1 year

Diagnostic Test

follow-up MRI at 1 year for asymptomatic patients under 35 years of age not wanting to undergo surgery

Primary outcomes

  1. The Prevalence of Appendiceal Tumours in Periappendicular Abscess

    Time frame: 2-3 months (interval appendectomy)

    The Prevalence of Appendiceal Tumours in Patients Presenting With a Periappendicular Abscess - A Nationwide Prospective Cohort Study

Secondary outcomes

  1. Tympanic temperature

    Time frame: Day 0 (on primary admission)

    All patients

  2. Imaging (primary diagnosis) finding

    Time frame: Day 0 (on primary admission)

    All patients

  3. Duration of symptoms on admission

    Time frame: Day 0 (on primary admission)

    All patients

  4. Laboratory value: CRP

    Time frame: Day 0 (on primary admission) up to 3-5 days (discharge from the hospital)

    CRP

  5. Laboratory value: leuckocytes

    Time frame: Day 0 (on primary admission) up to 3-5 days (discharge from the hospital)

    leuk

  6. Laboratory value: neutrophils

    Time frame: Day 0 (on primary admission) up to 3-5 days (discharge from the hospital)

    neutr

  7. Laboratory value: hemoglobin

    Time frame: Day 0 (on primary admission) up to 3-5 days (discharge from the hospital)

    Hb

  8. Laboratory value: kreatinine

    Time frame: Day 0 (on primary admission) up to 3-5 days (discharge from the hospital)

    Krea

  9. Laboratory value: CEA

    Time frame: Day 0 (on primary admission) up to 3-5 days (discharge from the hospital) and up to 1 year, if no interval appendectomy

    CEA

  10. Laboratory value. Cg-A

    Time frame: Day 0 (on primary admission) up to 3-5 days (discharge from the hospital)and up to 1 year, if no interval appendectomy

    Cg-A

  11. Primary nonoperative treatment

    Time frame: Day 0 and up to one week

    All patients, treatment details

  12. Colonoscopy: endoscopic findings and histology

    Time frame: 2 weeks to 2 months prior to planned interval appendectomy

    In both intervention groups

  13. Interval appendectomy specimen histology

    Time frame: At 3 months

    Interval appendectomy patients

  14. Complications after interval appendectomy

    Time frame: at the time of surgery

    Clavien-Dindo classification, interval appendectomy group

  15. Duration of hospital stay

    Time frame: up to 2 years

    All patients both at primary treatment, interval appendectomy and follow-up

  16. Follow-up MRI findings

    Time frame: at 1 year

    In case the patient does not under interval appendectomy

  17. follow-up CEA

    Time frame: at 1 year

    Follow-up MRI patients

  18. follow-up CgA

    Time frame: at 1 year

    Follow-up MRI patients

  19. Surgery after follow-up MRI

    Time frame: up to 10 years

    Follow-up with MRI patients

Study contacts

Contact information is provided by the study sponsor or research team.

Jenny Alajääski, MD

CONTACT

Paulina Salminen, prof, MD

CONTACT

[email protected]

+35823130000

Sponsors and collaborators

Lead sponsor

Turku University Hospital

Other Gov

Collaborators

  • Jyväskylä Central Hospital
  • Kuopio University Hospital
  • Lapland Central Hospital
  • Mikkeli Central Hospital
  • North Karelia Central Hospital
  • Oulu University Hospital
  • Päijänne Tavastia Central Hospital
  • Satakunta Central Hospital
  • Seinajoki Central Hospital
  • South Carelia Central Hospital
  • Tampere University Hospital
  • Vaasa Central Hospital, Vaasa, Finland

Registry information

Official study title

The Prevalence of Appendiceal Tumours in Patients Presenting With a Periappendicular Abscess - A Nationwide Prospective Cohort Study

Acronym: PeriAPPAC-T

Important dates

Study start
2020
Primary completion
2022
Study completion
2035
First posted
Nov 18, 2020
Registry last updated
Nov 18, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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